INCLUSION CRITERIA:
Establish with patient prior to Informed Consent:
- Adults 18 years of age or older.
- HIV-1 infection, as documented by a licensed ELISA test kit and confirmed by a Western blot assay at any time point prior to study entry or at study entry ( May do after informed consent if no test results are available).
Off all ARV for greater than or equal to three months prior to study entry, no documented evidence of viral resistance, and no evidence of acute HIV infection. For the purposes of this study acute HIV infection will be defined as presence of a detectable HIV-1 viral RNA in the presence of a non reactive HIV-1 or HIV-2 antibody assay or an indeterminate western blot. For the purposes of this study viral resistance is being defined as having a genotypic or phenotypic evidence of resistance or in the absence of formal resistance testing clinical evidence of resistance for e.g. patients with persistent viremia in the face of adequate adherence.
- Willingness to use a method of contraception during the study period. Adequate methods of birth control include: condoms, male or female, with or without a spermicide; diaphragm or cervical cap with spermicide; intrauterine device; any of the methods that require a prescription (such as contraceptive pills or patch, Norplant, Depo-Provera, and others) or a male partner who has previously undergone a vasectomy.
- Willingness to have blood drawn.
- Non known allergy or contraindication to atorvastatin use.
- Ability to understand and willingness to sign the informed consent.
- Willingness to have blood stored for future phenotyping and genotyping.
After Informed Consent:
- CD4 cell count greater than 350 cells/ml.
- 3 viral loads that average greater than 1000 copies/ml within a 4 week period.
- The viral loads will be done using the bDNA method in the NIH laboratory and must be within 20% (log10bDNA of each other).
- A fasting total cholesterol lower than 240mg/dl and a LDL cholesterol lower than 130mg/dl.
- Liver function tests (AST or ALT) not greater than 1.5 times the upper limit of normal. Evidence of active hepatitis B or C will not be considered an exclusion criteria if the liver function tests are within normal limits.
- Creatine phosphokinase elevations (CPK) not greater than 3 times the upper limit of normal (ULN) on two sequential determinations and, in the opinion of the investigator, without clear association with exercise.
- Laboratory values:
Absolute neutrophil count (ANC) greater than or equal to 1000/mm(3).
Hemoglobin greater than or equal to 11.0 g/dL.
Platelet count greater than or equal to 100,000/mm(3).
Creatinine less than or equal to 2 x ULN.
Serum amylase and lipase less than or equal to 1.25 x ULN.
- Negative serum pregnancy test at randomization.
EXCLUSION CRITERIA:
- Pregnancy or breast feeding.
- Active drug use or alcohol abuse/dependence, which in the opinion of the investigators will interfere with the patient's ability to participate in the study.
- Serious illness requiring systemic treatment and/or hospitalization within 30 days of entry.
- Evidence of active opportunistic infections or neoplasms that require chemotherapy during the study period except cutaneous Kaposi Sarcoma.
- Allergy or hypersensitivity to atorvastatin or any of its components.
- History of myositis or rhabdomyolysis with use of any statins.
- History of inflammatory muscle disease such as poly or dermatomyositis.
- Concomitant use of fibric acid derivatives or other lipid lowering agents including patients on statins and Ezetimibe.
- Concomitant use of drugs that have significant interactions with atorvastatin. Please see appendix II for a listing.
- Concomitant use of St.Johns wort.
- Concomitant use of Valproic acid.
- Patients who are on concurrent immunomodulatory agents, including systemic corticosteroids will be ineligible for 3 months after completion of therapy with the immunomodulating agents. Topical, nasal or inhaled corticosteroids use is not an exclusion criteria.
- Serum LDL cholesterol less than 40 mg/dl.
- Vaccinations within 6 weeks of study entry.
- Vaccinations within 6 weeks of study entry.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/20/2008